BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 1910188 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05279
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP WAS SEVERELY ELONGATED AND THE CORE WIRE WAS DETACHED/SEPARATED FORM DISTAL BALD WELD. EXCEPT WHERE NOTED, THE SPECIMEN APPEARED TO BE VISUALLY CORRECT. NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED. A MICROSCOPIC SEM ANALYSIS OF THE PROXIMAL PORTION OF THE CORE WIRE FRACTURE SITE REVEALED THAT THE FRACTURE SURFACE EXHIBITED FATIGUE STRIATIONS ALONG WITH ELONGATED DIMPLE RUPTURED IN TEAR PLANES WHICH IS INDICATIVE OF A BENDING ACTION. NO MATERIAL ANOMALIES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #: 2134265-2010-04848 AND 2134265-2010-04849. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6), 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE GUIDE WIRE TIP UNRAVELED. THE 80% STENOSED LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. DURING AN UNSPECIFIED TIME DURING THE PROCEDURE THE PHYSICIAN NOTED THAT THE .014 X 300CM PLATINUM PLUS GUIDE WIRE TIP HAD UNRAVELLED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. DEVICE ANALYSIS REVEALED THAT THE DISTAL TIP OF THE GUIDE WIRE WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M001467120 0013237926

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR GUIDE WIRE: .014 X 145CM PLATINUM PLUS| BALLOON CATHETER: 3MM X 40MM X 145CM STERLING